AsthmaPhase 3NCT00500539
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
A Phase 3 study testing omalizumab in people with Asthma, run by Novartis at 31 sites in 3 countries.
Trial summary
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- omalizumab
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 12 years old or above with moderate to severe allergic asthma
- Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
- Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
- Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
- No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
- Demonstrated evidence of inadequate asthma symptom control, despite treatment with ICS according to clinical features of moderate to severe persistent asthma.
Who cannot join
- Previous exposure to omalizumab
- Previous exposure to other humanized proteins or monoclonal antibodies
- Known HAHA to other monoclonal antibodies
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
- Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
- Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States26 sites
Georgia Pollen
Albany, Georgia, GA 31707
Allergy & Asthma Specialists, PC
Blue Bell, Pennsylvania, PA 19422
Allergy, Asthma and Clinical Immunology
Brick, New Jersey, NJ 08724
1st Allergy and Clinical Research Center
Centennial, Colorado, CO 80112
Allergy Center at Brookstone
Columbus, Ohio, OH 31904
The Corvallis Clinic, PC
Corvallis, Oregon, OR 97330
North Texas Institute for Clinical Trials
Fort Worth, Texas, TX 76132
Allergy and Asthma Center of NC, PA
High Point, North Carolina, NC 27262
Allergy and Asthma Associates
Houston, Texas, TX 77054
Clinical Trials of North Houston
Houston, Texas, TX 77070
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, OR97037
Innovative Research of West Florida, Inc.
Largo, Florida, FL 33770
Nassau Chest Pysicians, PC
Massapequa, New York, NY 11758
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, OR 97504
Asthma and Allergy Specialists, PA
Minneapolis, Minnesota, MN 55402
Asthma & Allergy Research of NJ, Inc.
Mount Laurel, New Jersey, NJ 08054
Kansas City Allergy & Asthma
Overland Park, Kansas, 66210
California Allergy and Asthma Medical Group
Palmdale, California, CA 93551
Asthma Allergy & Pulmonary Associates, PC
Philadelphia, Pennsylvania, PA 19107
AAPRI Clinical Research Institute
Providence, Rhode Island, RI 02906
Allergy Associates Medical Group, Inc,
San Diego, California, CA 92120
Allergy & Immunology Associates, Ltd
Scottsdale, Arizona, AZ 85251
: The Clinical Research Center, LLC
St Louis, Missouri, MO 63141
Bensch Research Associates
Stockton, California, CA 95207
Toledo Center for Clinical Research
Sylvania, Ohio, OH 43650
Asthma and Allergy Center
Toledo, Ohio, OH 43617
Argentina4 sites
Novartis Investigative Site,
Buenos Aires
Novartis Investigative Site
Buenos Aires
Novartis Investigative Site,
Corrientes
Novartis Investigative Site,
Mendoza
About this study
Official title: An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.
- Conditions
- Asthma
- Being tested
- omalizumab
- Keywords
- Asthma, omalizumab, safety, allergic asthma, adolescents
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period
An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.
Measured: 16 weeks after last dose
Secondary outcomes (2)
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period
The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.
Measured: 24 weeks treatment period + 4 weeks for following up participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period
The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).
Measured: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc., Tanox
- Investigators
- Jose Bardelas, MD, Principal investigator, Allergy and Asthma center of North Carolina, PA, High Point, NC 27262
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500539
- Sponsor's protocol ID
- CIGE025C2303
- Status last verified
- May 2011
- First submitted
- 11 Jul 2007
- Last updated
- 2 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1.
PubMed 24028677
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma
- ClinicalTrials.gov ID
- NCT00500539
- Acronym / sponsor ID
- CIGE025C2303
- Conditions
- Asthma
- Keywords
- Asthma, omalizumab, safety, allergic asthma, adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc., Tanox
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 27 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 12 years old or above with moderate to severe allergic asthma
- Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
- Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
- Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
- No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
Key exclusion criteria (7 listed)
- Previous exposure to omalizumab
- Previous exposure to other humanized proteins or monoclonal antibodies
- Known HAHA to other monoclonal antibodies
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumabThe liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe. | Drug | – |
Primary outcome
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period
Time frame: 16 weeks after last dose
An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.
2 secondary outcomes
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period
Time frame: 24 weeks treatment period + 4 weeks for following up participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period
Time frame: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24028677Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Bardelas, MD principal investigator
Allergy and Asthma center of North Carolina, PA, High Point, NC 27262
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omalizumab in people with Asthma, run by Novartis at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Argentina, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period (time frame: 16 weeks after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.